Last updated: June 27, 2022
Sponsor: Fitlens Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myopia
Treatment
N/AClinical Study ID
NCT05433792
FL-CN/CF-01
Ages 8-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Be between 8 and 12 years of age inclusive at baseline examination.
- The participant has been given a detailed, clear explanation concerning the studyaspects and procedures.
- The participant's parents or legal guardian have been given a clear explanation, thenread, understood, and signed the informed consent form.
- Willingness to adhere to protocol, agreement to maintain the visit schedule.
- Along with their parent or guardian, agree to maintain the visit schedule and be ableto keep all appointments as specified in the study protocol for the duration of thestudy.
- Agreement to wear the assigned contact lenses for a minimum of 10 hours per day, atleast 6 days per week, for the duration of the 3-year study.
- Subject with normal eyes who is not using any ocular medications.
- Possess wearable and visually functional eyeglasses.
- Be in good general health, based on his/her and parent's/guardian's knowledge.
- Best-corrected visual acuity by manifest refraction of +0.10 log MAR (20/25 or 6/7.5)or better in each eye. (Lens power required limited to up to minus 10).
- The manifest cylinder is less than or equal to 0,75D.
- Meet the following refractive criteria determined by cycloplegic autorefraction atbaseline (per eye):
- Spherical equivalent refractive error: between -0.75 and -4.00 D inclusive.
- Astigmatism: ≤-0.75 D
- Anisometropia: <1.00 D
Exclusion
Exclusion Criteria:
- Subject is currently or within 30 days before this study has been an activeparticipant in another clinical study involving an investigational treatment.
- Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine,or any other myopia control treatment.
- Birth earlier than 30 week or <1500 g (3.3 lb) at birth.
- Regular use of ocular medications, artificial tears, or wetting agents.
- Current use of systemic medications, which may affect contact lens wear, tear filmproduction, pupil size, accommodation, or refractive state.
- A known allergy to any of the Myolens components.
- A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,corneal infiltrates, ocular viral or fungal infections, or other recurrent ocularinfections.
- Strabismus by cover test at distance or near wearing distance correction.
- History of any of the following: ocular or systemic diseases, including those thatcould influence refractive development, anterior segment infection, inflammation orabnormality, any active anterior segment ocular disease that would contraindicatecontact lens wear; history of herpetic keratitis; history of refractive surgery orirregular cornea (except when the contact lenses under investigation are indicated forirregular cornea, keratoconus or refractive surgery); a pathologically dry eye.
- Keratoconus or an irregular cornea (assessed by corneas topography)
- Contraindications for contact lens wear including giant papillary conjunctivitis ofgrade 2 or worse and allergic or seasonal conjunctivitis (assessed by slit lamp exam)
- Subject seems to exhibit poor personal hygiene (that in the investigator's opinionmight prevent safe contact lens wear) or the investigator for any reason considersthat it is not in the best interest of the subject to participate in the study.
- Slit lamp findings that are more serious than grade 1 according to the Efron GradingScale.
- Corneal vascularization greater than 1 mm of penetration
Study Design
Total Participants: 66
Study Start date:
May 10, 2022
Estimated Completion Date:
January 31, 2026
Study Description
Connect with a study center
Wolfson Medical Center
Holon,
IsraelActive - Recruiting
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